Royal Dental Lab
Manufacturer and brand owner in Shenzhen, Guangdong, China. 12 device types, 1 product catalogued, 1 clearance.
Royal Dental Lab is a manufacturer holding a current FDA establishment registration. The registration covers Dentures, Full, Crown, Preformed and 10 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2003.
12device types registered with the FDA
1product
1510(k) clearance
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3004086183 |
| FEI number | 3004086183 |
| DUNS | 529128636 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市金悠然科技有限公司 |
|---|---|
| Unified social credit code | 91440300676655701B |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | F/1, 2, 3, 5, 6, Building 2, No. 4 West Area |
| Postal code | 518129 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Aligner, Sequential | Class 2 | Clear Aligner | 2020 | 14 |
| Crown, Preformed | Class 1 | Crown, Preformed | 2003 | 23 |
| Dentures, Full | Class N | Dentures, full | 2011 | 50 |
| Dentures, Partial | Class N | Acrylic Partial, Cast Partial | 2011 | 55 |
| Positioner, Tooth, Preformed | Class 1 | Preformed Tooth Positioner | 2018 | 19 |
| Prosthesis, Orthodontic | Class N | Customized Orthodontic Appliance/Device | 2011 | 29 |
| Restoration, Base Metal | Class N | Full Metal Crown/Bridge/Inlay/Onlay with Non-Precious Alloy | 2011 | 43 |
| Restoration, Noble Metal | Class N | Restoration, noble metal | 2011 | 42 |
| Restoration, Porcelain | Class N | All Ceramic Restoration | 2011 | 50 |
| Restoration, Porcelain-Fused-To-Metal | Class N | Restoration, porcelain-fused-to-metal | 2011 | 50 |
| Restoration, Resin, Crown And Bridge | Class N | Restoration, resin, crown and bridge | 2011 | 35 |
| Teeth, Artificial, Backing And Facing | Class 1 | Veneer | 2025 | 9 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Aligner, Sequential | NXC | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K192767 | 2020-01-08 | NXC | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1994 |
|---|---|
| Main products | Dental prosthetics, Zirconia implants, Ceramic crowns, Clear aligners, Dental veneers |
| Certifications | ISO 9001, ISO 13485, FDA 3004086183, ISO 14001, National High-Tech Enterprise |
| Export markets | Over 20 countries including US, Germany, UK, France, Italy, Australia |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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